JIT · Class II · 21 CFR 862.1150

FDA Product Code JIT: Calibrator, Secondary

Leading manufacturers include Dade Behring, Inc., Roche Diagnostics Corp. and E.I. Dupont DE Nemours & Co., Inc..

245
Total
245
Cleared
59d
Avg days
1976
Since
245 devices
49–72 of 245
Cleared Oct 27, 1998
FERRITIN CALIBRATOR
K983548
Dade Behring, Inc.
Immunology · 18d
Cleared Aug 13, 1998
PREALBUMIN CALIBRATOR
K982292
Dade Behring, Inc.
Chemistry · 44d
Cleared Apr 16, 1998
STRATUS CS CKMB CALPAK
K981097
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 16, 1998
STRATUS CS TROP CALPAK
K981100
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 15, 1998
STRATUS CS MYO CALPAK
K981101
Dade Behring, Inc.
Chemistry · 20d
Cleared Jun 16, 1997
ELECSYS CEA ASSAY
K964368
Boehringer Mannheim Corp.
Immunology · 227d
Cleared Mar 11, 1994
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR
K934843
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 154d
Cleared Aug 15, 1989
CHLORIDE STANDARDS ITEM #SR1041
K891999
Em Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Dec 14, 1987
PARAMAX ISE CHLORIDE CALIBRATOR
K873743
Baxter Healthcare Corp
Chemistry · 89d
Cleared May 26, 1987
ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8
K871150
Beckman Instruments, Inc.
Chemistry · 64d
Cleared Mar 19, 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR
K870673
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 28d
Cleared Aug 19, 1986
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
K862525
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Sep 13, 1984
ROCHE STANDARDS FOR URIC ACID
K843112
Roche Diagnostic Systems, Inc.
Chemistry · 37d
Cleared Jan 04, 1984
ACA THYROXINE UPTAKE CALIBRATOR
K833702
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 78d
Cleared Dec 27, 1983
ACA THYROXINE CALIBRATOR
K833700
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 70d
Cleared Aug 31, 1978
DUAL COMPONENT STANDARDS
K781423
Abbott Laboratories
Chemistry · 14d
Cleared Apr 05, 1978
CALIBRATORS, CARBON DIOXIDE
K780295
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 43d
Cleared Oct 25, 1977
ACA TRIGLYCERIDE CALIBRATOR
K771797
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA CARBON DIOXIDE CALIBRATOR
K771801
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA IRON CALIBRATOR
K771802
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA PHOSPHORUS CALIBRATOR
K771803
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA AMMONIA CALIBRATOR
K771804
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Dec 21, 1976
CHOLESTEROL CALIBRATOR
K761197
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Oct 05, 1976
BILIRUBIN REF., SIGMA STOCK NO. 605-10
K760349
Sigma Chemical Co.
Chemistry · 64d